DEVICE: Platinum (B679KGH10)

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Device Record History
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Device Identifier (DI) Information
Platinum
KGH1
Not in Commercial Distribution
KGH1
SUMMUS MEDICAL LASER, LLC
B679KGH10
HIBCC
July 19, 2019
1
621560338 *Terms of Use
Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60409 Musculoskeletal/physical therapy laser, professional
An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
1d390db1-e311-4f90-a8f0-dbc283872d08
January 10, 2025
13
June 27, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
850-584-7117
perrychiro@hotmail.com
972-287-7733
drwordwordchiro@gmail.com
615-907-7400
dr.stanlickstanlickchiropractic@gmail.com
864-420-2997
maryfrancesduncan@gmail.com
480-767-2768
kellieevophysicaltherapy@gmail.com
(215) 646-6400
drsiscoe@gmail.com
(864) 908-7873
drjennatitcombe@gmail.com
(214) 348-3516
michelew@inmotionpts.com
(702) 202-0808
info@uppercervicalchiropracticlv.com
(615) 907-7400
dr.stanlick@stanlickchiropractic.com
(972) 287-7733
drword@wordchiro.com
(303) 718-8562
matthew.dilallo@gmail.com
864 420 2997
maryfrancesduncan@gmail.com
603 448 0048
tmosenthaldc@gmail.com
727 384 4111
rclifford@allcareptc.com
812 288 7999
purduedvm@aol.com
(540) 434-5544
lbomp30@gmail.com
(573) 776-7246
kody.berrong@gmail.com
(562) 296-5528
jenkim14@gmail.com
(716) 650-7246
cmilioto@buffspine.com
(787) 764-5879
esiverio@prtc.net
(609) 234-4222
drlaw@jointspinecenter.com
(208) 356-8818
elevatedchiro.chant@gmail.com
(678) 469-4133
structuralbasedtherapy@gmail.com
(805) 715-1537
drdaveshouse@gmail.com
(630) 339-5300
drkc@gcspdocs.com
503-975-5531
drcoryharkins@gmail.com
(510) 446-2225
bayareabacktowellness@gmail.com
(270) 852-9355
aaronpclark@hotmail.com
(724) 202-6490
dholmes@elitesports-spine.com
(320) 295-3027
jim@nelsonchiro.net
(239) 214-0214
ksfoijfsfsd@none.com
(904) 940-9401
yourvet@murabellaanimalhospital.com
(334) 844-9891
athletic_director@auburn.edu
(434) 409-5150
drjohn@patriotspointchiro.com
(727) 712-4347
jrauch@phillies.com
(615) 595-7749
dbradley@summuslaser.com
(615) 595-7749
richport4@gmail.com
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